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Thrombolysis in Pediatric Stroke (TIPS)

NCT01591096 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2018-05-25

Study results available
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Summary

Thrombolysis in Pediatric Stroke (TIPS) is a five-year multi-center international safety and dose-finding study of intravenous (IV) tPA in children with acute ischemic stroke (AIS) to determine the maximal safe dose of intravenous Tissue Plasminogen Activator (IV-tPA) among three doses (0.75. 0.9, 1.0 mg/kg) for children age 2-17 years within 4.5 hours from onset of acute AIS.

Conditions

Interventions

DRUG

Tissue plasminogen activator (Activase®)

Investigation labeled tPA will be obtained for all sites by the Core Pharmacy as commercially available recombinant tPA (Genentech as Activase®) for IV administration. The Bayesian method of toxicity probability intervals will be used to select one of the following three dose tiers (0.75, 0.9, 1.0 mg/kg) of IV tPA. The dose escalation for the two age groups (2-10, 11-17 years) will be performed independently. The maximum dose for each tier will be reached at a weight of 90 kg.

Sponsors & Collaborators

  • The Hospital for Sick Children

    collaborator OTHER

  • Medical College of Wisconsin

    collaborator OTHER

  • University of Texas at Austin

    collaborator OTHER

  • Alberta Children's Hospital

    collaborator OTHER

  • McMaster University

    collaborator OTHER

  • Seattle Children's Hospital

    lead OTHER

Principal Investigators

  • Catherine Amlie-Lefond, MD · Seattle Children's Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • United States
  • Canada

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01591096 on ClinicalTrials.gov